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Study Of The Effects Of Atorvastatin On Cholesterol Levels In Rheumatoid Arthritis Patients Taking CP-690,550

NCT ID: NCT01059864

Last Updated: 2012-12-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-11-30

Brief Summary

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All patients will be in instructed to eat a therapeutic lifestyle diet and will receive CP-690,550 throughout the 12 weeks of this study. After 6 weeks, half will receive the cholesterol lowering agent, atorvastatin, and half a matching placebo. This study will first measure the effects of CP-690,550 on cholesterol levels and then the effects of adding atorvastatin on those levels.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Keywords

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cholesterol lipids rheumatoid arthritis CP-690 550

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm 1

Group Type EXPERIMENTAL

CP-690,550

Intervention Type DRUG

12 week open-label CP-690,550 10 mg oral tablets administered twice daily starting at Day 0 through Week 12

Atorvastatin

Intervention Type DRUG

Starting at Week 6 and continuing through Week 12 atorvastatin 10 mg oral tablets administered once daily

Arm 2

Group Type EXPERIMENTAL

CP-690,550

Intervention Type DRUG

12 week open-label CP-690,550 10 mg oral tablets administered twice daily starting at Day 0 through Week 12

Atorvastatin Placebo

Intervention Type DRUG

Starting at Week 6 and continuing through Week 12 atorvastatin placebo tablets administered once daily

Interventions

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CP-690,550

12 week open-label CP-690,550 10 mg oral tablets administered twice daily starting at Day 0 through Week 12

Intervention Type DRUG

Atorvastatin

Starting at Week 6 and continuing through Week 12 atorvastatin 10 mg oral tablets administered once daily

Intervention Type DRUG

CP-690,550

12 week open-label CP-690,550 10 mg oral tablets administered twice daily starting at Day 0 through Week 12

Intervention Type DRUG

Atorvastatin Placebo

Starting at Week 6 and continuing through Week 12 atorvastatin placebo tablets administered once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* must be diagnosed as having active rheumatoid arthritis
* agree to participate in the study and sign and informed consent document

Exclusion Criteria

* History of serious infection within the past 6 months
* test positive for TB
* have any uncontrolled clinically significant disease or laboratory tests
* require administration of prohibited medications during the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Birmingham, Alabama, United States

Site Status

Pfizer Investigational Site

Huntsville, Alabama, United States

Site Status

Pfizer Investigational Site

Gilbert, Arizona, United States

Site Status

Pfizer Investigational Site

Scottsdale, Arizona, United States

Site Status

Pfizer Investigational Site

Upland, California, United States

Site Status

Pfizer Investigational Site

Jacksonville, Florida, United States

Site Status

Pfizer Investigational Site

Dayton, Ohio, United States

Site Status

Pfizer Investigational Site

Mayfield Village, Ohio, United States

Site Status

Pfizer Investigational Site

Greenville, South Carolina, United States

Site Status

Pfizer Investigational Site

Allen, Texas, United States

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Pfizer Investigational Site

Seoul, , South Korea

Site Status

Countries

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United States South Korea

References

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Hetland ML, Strangfeld A, Bonfanti G, Soudis D, Deuring JJ, Edwards RA. Machine learning prediction and explanatory models of serious infections in patients with rheumatoid arthritis treated with tofacitinib. Arthritis Res Ther. 2024 Aug 27;26(1):153. doi: 10.1186/s13075-024-03376-9.

Reference Type DERIVED
PMID: 39192350 (View on PubMed)

Charles-Schoeman C, Hyde C, Guan S, Parikh N, Wang J, Shahbazian A, Stockert L, Andrews J. Relationship Between Paraoxonase-1 Genotype and Activity, and Major Adverse Cardiovascular Events and Malignancies in Patients With Rheumatoid Arthritis Receiving Tofacitinib. J Rheumatol. 2023 Jul 15:jrheum.2023-0112. doi: 10.3899/jrheum.2023-0112. Online ahead of print.

Reference Type DERIVED
PMID: 37453736 (View on PubMed)

Kristensen LE, Danese S, Yndestad A, Wang C, Nagy E, Modesto I, Rivas J, Benda B. Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance. Ann Rheum Dis. 2023 Jul;82(7):901-910. doi: 10.1136/ard-2022-223715. Epub 2023 Mar 17.

Reference Type DERIVED
PMID: 36931693 (View on PubMed)

Hansen KE, Mortezavi M, Nagy E, Wang C, Connell CA, Radi Z, Litman HJ, Adami G, Rossini M. Fracture in clinical studies of tofacitinib in rheumatoid arthritis. Ther Adv Musculoskelet Dis. 2022 Dec 27;14:1759720X221142346. doi: 10.1177/1759720X221142346. eCollection 2022.

Reference Type DERIVED
PMID: 36601090 (View on PubMed)

Curtis JR, Yamaoka K, Chen YH, Bhatt DL, Gunay LM, Sugiyama N, Connell CA, Wang C, Wu J, Menon S, Vranic I, Gomez-Reino JJ. Malignancy risk with tofacitinib versus TNF inhibitors in rheumatoid arthritis: results from the open-label, randomised controlled ORAL Surveillance trial. Ann Rheum Dis. 2023 Mar;82(3):331-343. doi: 10.1136/ard-2022-222543. Epub 2022 Dec 5.

Reference Type DERIVED
PMID: 36600185 (View on PubMed)

Winthrop KL, Yndestad A, Henrohn D, Danese S, Marsal S, Galindo M, Woolcott JC, Jo H, Kwok K, Shapiro AB, Jones TV, Diehl A, Su C, Panes J, Cohen SB. Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs. Rheumatol Ther. 2023 Apr;10(2):357-373. doi: 10.1007/s40744-022-00507-z. Epub 2022 Dec 17.

Reference Type DERIVED
PMID: 36526796 (View on PubMed)

Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.

Reference Type DERIVED
PMID: 34870800 (View on PubMed)

Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395.

Reference Type DERIVED
PMID: 33127856 (View on PubMed)

Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20.

Reference Type DERIVED
PMID: 32816215 (View on PubMed)

Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017 Jul;76(7):1253-1262. doi: 10.1136/annrheumdis-2016-210457. Epub 2017 Jan 31.

Reference Type DERIVED
PMID: 28143815 (View on PubMed)

Cohen S, Radominski SC, Gomez-Reino JJ, Wang L, Krishnaswami S, Wood SP, Soma K, Nduaka CI, Kwok K, Valdez H, Benda B, Riese R. Analysis of infections and all-cause mortality in phase II, phase III, and long-term extension studies of tofacitinib in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014 Nov;66(11):2924-37. doi: 10.1002/art.38779.

Reference Type DERIVED
PMID: 25047021 (View on PubMed)

McInnes IB, Kim HY, Lee SH, Mandel D, Song YW, Connell CA, Luo Z, Brosnan MJ, Zuckerman A, Zwillich SH, Bradley JD. Open-label tofacitinib and double-blind atorvastatin in rheumatoid arthritis patients: a randomised study. Ann Rheum Dis. 2014 Jan;73(1):124-31. doi: 10.1136/annrheumdis-2012-202442. Epub 2013 Mar 12.

Reference Type DERIVED
PMID: 23482473 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921109&StudyName=Study%20Of%20The%20Effects%20Of%20Atorvastatin%20On%20Cholesterol%20Levels%20In%20Rheumatoid%20Arthritis%20Patients%20Taking%20CP-690%2C550

To obtain contact information for a study center near you, click here.

Other Identifiers

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A3921109

Identifier Type: -

Identifier Source: org_study_id